Auto-injector

ABSTRACT

An auto-injector operable in a single activation step. The auto-injector is automatically armed when removed from its carrying receptacle. The auto-injector may be prefilled with more than one constituent of a beneficial agent, stored in separated compartments, in such an arrangement that the compartments will automatically merge when the auto-injector is removed from its carrying receptacle.

FIELD

The present disclosure pertains to the field of parenteral drugdelivery, and more particularly to prefilled injection devices.

BACKGROUND

Auto-injectors are used for clinical parenteral administration of afixed dose of a beneficial agent to a subject. They are particularlyadvantageous, and hence more commonly practiced, in emergencyapplications in which proper administration, potentially by an untrainedor minimally trained user, under extreme duress, in less than optimalconditions, is needed to be perform in a timely manner. Auto-injectorsare more proper for these applications than regular syringes as theyrequire fewer and simpler to implement operative steps. It is hence animportant aspect of auto-injector design to minimize the number andcomplexity of the operation steps of an auto-injector. Manyauto-injector technologies require two hand preparation of the devicefor injection, such as arming of the device, release of a safety catch,and removal of an aseptic barrier that ensure the sterility of thedevice until the time of use. According to one usability aspect ofauto-injectors, the need to perform two hand operations introduces alevel of complexity and confusion to the user, as eventually the devicehas to be properly repositioned, in the proper orientation, in the handthat is used for administration.

One example of an commonly used auto-injector is the EpiPen®manufactured by Meridain Medical Technologies (Columbia, Md.). TheEpiPen® applies a spring force to automatically deliver a dose ofepinephrine from a glass syringe. The EpiPen® requires two handoperation to remove a cap and arm the device, at the end of which thedevice needs to be reoriented and properly grasped by the hand thatdelivers the injection. Several publications describe user error inhandling the EpiPen® where the user applies the wrong side of theEpiPen® auto-injector to the subject, and wasting the medication dosetoward the opposite side (away from the target injection site).

U.S. Pat. No. 8,425,462 teaches an auto-injector propelled by a CO₂cartridge. The auto-injector has an actuation guard that is removable toallow activation of the device. Two hand operation is required to removethe actuation guard and prepare the device for injection. As a result,it is likely that reorientation of the device and change in hand graspwould be performed during preparation for injection.

U.S. Pat. No. 6,979,316 teaches an auto-injector operated by a spring. Amolded safety cover is fitted onto the forward end of the housing andmaintains the sterility of the internal components and also preventsinadvertent actuation of the device. The safety cover must be removedfrom the device before it can be used.

In similar fashion, other auto-injector technologies, in commercialembodiments and in published documentation, require two hand operationto prepare for injection and bare the risk of mishandling foradministration.

SUMMARY

According to some embodiments described herein, an auto-injector isdescribed that is activatable to administer a beneficial agent to asubject. The auto-injector is configured to be operable single-handedly,without changing the hand grasp of the auto-injector body, from apre-used configuration in its storage or carrying package or receptacle,to administration. According to some embodiments described herein, theauto-injector automatically mixes components of the beneficial agentwithout altering the operation simplicity. According to some embodimentsdescribed herein, the auto-injector further comprises an ornamentalfeature to facilitate tactile and visual recognition of the device.According to some embodiments described herein, a first auto-injectorcan be stored or carried with a second auto-injector, and the firstauto-injector comprises at least one of ornamental, graphical, and colorrecognition feature allowing a user to at least one of tactile andvisually differentiate the first auto-injector from the secondauto-injector. According to some embodiments described herein, theauto-injector provides tactile, visual, and audible feedback when it ismoved from the pre-use configuration to the armed configuration, fromthe armed configuration to administration, and/or when administration iscompleted. Embodiments of the auto-injector described herein is designedto minimize user errors.

According to some embodiments described herein, the auto-injectorarrangement comprises (a) an auto-injector comprising an injector bodyhousing a beneficial agent, and (b) an actuator moveably connected tothe auto-injector, the actuator comprising an anchoring link adapted tobe connected to an anchoring body, wherein when in a first auto-injectorarrangement state, the auto-injector is rendered incapable of expellingthe beneficial agent, and when in a second auto-injector arrangementstate, corresponding to the auto-injector having being moved relative tothe anchoring body from the first auto-injector arrangement state, theauto-injector is rendered capable of expelling the beneficial agent.

According to some embodiments described herein, the auto-injector,comprises (a) an injector housing having an injection end, (b) anadministration assembly disposed within the injector housing, theadministration assembly having a delivery end proximate to the injectionend through which a beneficial agent housed within the administrationassembly is capable of being expelled, and (c) an actuator moveablyconnected to the administration assembly, wherein when in a firstauto-injector state, the actuator is coupled to the administrationassembly such that the delivery end is rendered incapable of beingapplied to a subject and the administration assembly is renderedincapable of expelling the beneficial agent, and when in a secondauto-injector state, corresponding to the actuator having beenmanipulated from the first auto-injector state, the administrationassembly is rendered capable of expelling the beneficial agent, theauto-injector thereafter movable into a third auto-injector state inwhich the actuator is separated from the auto-injection.

In some embodiments described herein, the auto-injector can be carriedin a receptacle in a safe configuration, and is armed when removed fromthe receptacle. In the safe mode the auto-injector will not activateunder any carrying conditions including when it is exposed to externalforce, shock, vibration, or other environmental condition. When removedfrom the receptacle the auto-injector changes from the safeconfiguration to armed configuration. In some arrangements, in the armedconfiguration the auto-injector is automatically activated by depressingthe injection side of the auto-injector against an injection site of asubject. In some arrangements activation of the auto-injector triggersan injection sequence comprising deploying a needle from a concealedposition in the auto-injector body, delivering the beneficial agent, andretracting the needle. In some arrangements the auto-injector stores atleast two constituents of a beneficial agent, in separated compartments,and the compartments are automatically merged when the auto-injector isremoved from the carrying receptacle. The carrying receptacle may by,but not limited to, a carrying case, a pouch, a pocket, a cradle, ahanger, a bracket, a box, a kit, a belt, or any combination thereof, orother carrying receptacles know in the art.

In some embodiments, the auto-injector comprises a removable link havinga first end attached to the auto-injector and a second end attached toan attachment point at or in proximity to the carrying receptacle, andthe arrangement is such that when the auto-injector is removed from thecarrying receptacle the removable link is pulled and causes theauto-injector to arm. After the auto-injector is armed, the removablelink is detached either from the attachment point and/or theauto-injector. The removable link may be one of, but not limited to, astrap, a string, a chain a rope, a cable, a combination of the above, orany other linking mechanism known in the art. In some arrangements theauto-injector comprises a removable cap that is attached to theremovable link, and the arrangement is such that when the removable linkpulls on the removable cap, the removable cap manipulates theauto-injector to an armed configuration, before the cap is removed fromthe auto-injector. In some arrangements the auto-injector comprises aremovable link and at least two constituents of a beneficial agent,separately stored in individual compartments, and the arrangement issuch that when the removable link is pulled, the auto-injector ismanipulated to merge these compartments. In some arrangements theauto-injector comprises a removable link joined to a removable cap, andat least two constituents of a beneficial agent, separately stored inindividual compartments, and the arrangement is such that when theremovable link pulls the removable cap, the auto-injector is manipulatedto merge these compartments.

In some embodiments described herein, the auto-injector is movable froma safe, pre-use configuration to an armed configuration, and while inthe carrying receptacle the auto-injector is maintained in the safeconfiguration. A spring biases the auto-injector toward the armedconfiguration such that when the auto-injector is removed from thecarrying receptacle the spring moves the auto-injector from a safeconfiguration to the armed configuration.

In some embodiments described herein, the carrying receptacle isconfigured in such a way that the hand grasp necessary for removal ofthe auto-injector from the receptacle is substantially similar to thehand grasp for injection such that the auto-injector can besingle-handedly operated without substantially changing the hand grasp,from the removal from the carrying receptacle, all the way to completionof the injection procedure. In some arrangements the carrying receptacleand the removable link are configured in such a way that the hand graspnecessary for removal of the auto-injector from the receptacle issubstantially similar to the hand grasp for injection such that theauto-injector can be single-handedly operated without substantiallychanging the hand grasp, from the removal from the carrying receptacleall the way to completion of the injection procedure. In somearrangements the carrying receptacle, the removable link, and theremovable cap are configured in such a way that the hand grasp necessaryfor removal of the auto-injector from the receptacle is substantiallysimilar to the hand grasp for injection such that the auto-injector canbe single-handedly operated without substantially changing the handgrasp, from the removal from the carrying receptacle to completion ofthe injection procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-1f illustrate a first arrangement of an auto-injector accordingto various embodiments described herein and the operation sequenceconfigurations thereof;

FIGS. 2a-2e illustrate a reconstitution arrangement of an auto-injectoraccording to various embodiments described herein;

FIGS. 3a-3d illustrate an auto-injector arrangement comprising ananchoring link according to various embodiments described herein;

FIGS. 4a-4c illustrate an auto-injector arrangement comprising areceptacle according to various embodiments described herein;

FIGS. 5a and 5b illustrate an auto-injector for simultaneous injectionsaccording to various embodiments described herein;

FIGS. 6a-6c illustrate an arrangement of an auto-injector comprising acap and a tube package according to various embodiments describedherein;

FIG. 7 illustrates an auto-injector with a tactile and visualdistinguishable ornamental end piece according to various embodimentsdescribed herein;

FIG. 8 illustrates an auto-injector with another tactile and visualdistinguishable ornamental end piece according to various embodimentsdescribed herein;

FIG. 9 illustrates an auto-injector with yet another tactile and visualdistinguishable ornamental end piece according to various embodimentsdescribed herein;

FIG. 10 illustrates an auto-injector with still another tactile andvisual distinguishable ornamental end piece according to variousembodiments described herein;

FIGS. 11a-11f illustrate an auto-injector arrangement comprising ananchoring link and a receptacle, configured for a single hand operation,according to various embodiments described herein;

FIGS. 12a and 12b illustrate a receptacle comprising a cap, configuredfor twist-off arming, according to various embodiments described herein;

FIGS. 13a-13n illustrate an auto-injector arrangement and detailedoperation sequence steps according to various embodiments describedherein;

FIG. 14a-14f illustrate two manufacturing process options of anauto-injector according to various embodiments described herein; and

FIGS. 15a and 15b illustrate an arrangement of an arming mechanism of anauto-injector according to various embodiments described herein.

DETAILED DESCRIPTION

FIGS. 1a-1f illustrate a simplified arrangement of an auto-injector 100of the present disclosure teaching the basic principles of itsconstruction and operation. FIGS. 1a and 1b illustrate an arrangement ofthe auto-injector 100 comprising a shell 102 (hereafter, by itself or incombination with other auto-injector elements, sometimes referred to asthe auto-injector housing or auto-injector body), and a needle housing101, together defining the external shell of the auto-injector 100. Theauto-injector 100 has a generally elongated cylindrical form comprisinga proximal end (hereafter sometimes referred to as the injection end)101 comprising a needle port 103, and distal end 102, where theauto-injector 100 may be hand grasped during the injection procedure. Amovable piston assembly (also referred to as the administrationassembly) 120 separates the interior volume of the auto-injector into apressure chamber 104 and a sterile needle housing 105. Theadministration assembly 120 comprises a piston 121, a beneficial agentpackage assembly 130 joined to its distal end, within the pressurechamber 104, and a movable needle assembly 140 joined at its proximalend, within the needle housing 105. The needle assembly 140 comprises aneedle 141 comprising a proximal sharp end and a distal sharp end, and aneedle hub 142, and is movable between a first pre-use position and asecond injection position, as will be detailed in the following Figures.The package assembly 130 comprises a first flexible wall 131 and asecond wall 132 joined along their peripheral edges in a permanent sealfashion. The first package wall 131 and the second package wall 132 arefurther joined across the package to form a first frangible seal 136defining a first compartment 134 adjacent to a second compartment 135. Asecond frangible seal 137 separates between the compartments 134-135 anda fitment 138 that is joined to the piston 121. The first compartment134 and the second compartment 135 may be filled with at least onebeneficial agent or constituents thereof. The fitment 138 comprises amembrane section 139 confronting the distal sharp end of the needle 141.A spring 114 biases the piston assembly toward the pressure chamber 104.An adhesive label 115 seals over the needle port 103 to maintain theneedle 141 sterile until the time of use. FIG. 1c illustrates aconfiguration of the auto-injector 100 where the first compartment 134and the second compartment 135 have been merged, by breaking the firstfrangible seal 136, allowing the at least first beneficial agentconstituent in the first compartment 134 and at least a secondconstituent in the second compartment 134 to mix and or interact. Thepackage 130 may comprise more than two mergeable compartments. FIG. 1dis showing a configuration of the auto-injector 100 where the secondfrangible seal (137 in FIG. 1a ) of the package assembly 130 has beenruptured establishing fluid communication between the beneficialagent(s) and the fitment 138. FIG. 1d illustrates an injectionconfiguration of the auto-injector 100, wherein pressure is introducedinto the pressure chamber 104 in the auto-injector body. The pressure isintroduced from a pressure source that when opened creates pressure inthe auto-injector body. When the pressure surpasses a first thresholdvalue, the pressure causes the piston to overcome the spring 113 forcedisplacing the needle assembly 120 toward the proximal end 101. Theneedle assembly 140 moves along with the piston until the needle hub 142stops against the bottom of the needle housing 112. During usage of theauto-injector 100, in this configuration it is held at the distal end102 while the proximal end 101 is depressed against an injection site ofa subject, such that the proximal end of the needle 141 is inserted intothe subject. An arrangement of the pressurizing mechanism of thepressure chamber 104 is shown in following Figures. In FIG. 1e thepiston assembly 120 continues its displacement toward the proximal end101, while the needle assembly 140 is stationary, causing the back endof the needle 142 to pierce the membrane (139 in FIG. 1b ) of thefitment 138, thereby establishing fluid communication between thepackage assembly 130 and the needle 141. The pressure in the pressurechamber 104 causes the first wall 131 to collapse and deliver thebeneficial agent(s) through the needle 141. The pressure in the pressurechamber 104 is gradually reduced by releasing the gas within through ableeding arrangement (not shown). FIG. 1f illustrates a configuration ofthe auto-injector 100 after the pressure in the pressure chamber 104 hasdropped to such a degree that the spring 113 can displace the needleassembly 120 toward the distal end 102 of the auto-injector 100 untilthe needle is concealed again in the needle housing 112.

FIG. 2a illustrates an arrangement of an auto-injector 200 comprising anauto-injector body comprising a shell 102 and a needle housing 112 whichtogether form the exterior of the auto-injector 200. A piston assembly120 is disposed in the auto-injector body (hereafter can be referred toas the auto-injector housing) and comprises a piston 121, accommodatinga package assembly 130 at its distal side, and a needle assembly 140 atits proximal side. An actuation assembly 210 is disposed in the pressurechamber 104, comprising a support structure 213 which hold in alignmenta pressurized cartridge 211 in a confronting position to a piercing pin212. The support structure 213 further accommodates a compression panel214 for manipulating the compartment of the package assembly 130 tomerge. FIG. 2b illustrates a cross section of auto-injector 200 in thefirst auto-injector state (hereafter can be referred to as the pre-useconfiguration). The compression panel 214 confronts the firstcompartment 134 on its first side and leans against a cam 221 at itssecond side. The cam 221 is fixed to the shell 102. A latch feature 222is also fixed to the shell 102. The pin's 212 sharp end is facing thepierceable region of the pressurized cartridge 211, and is free to movealong its axis. However in this configuration nothing can apply an axialforce to the pin 212 and hence an accidental piercing of the cartridge211 is not possible. FIG. 2c illustrates a second auto-injector stateand an mixing auto-injector state wherein the shell 102 is extended awayfrom the needle housing 112, causing the cam 221 to push the compressionpanel 214 which in return depresses the package 130 causing itscompartments to merge, and establish fluid communication with thefitment 138. The support structure 213 holds the pin 212 from movingupward while the latch feature 222 moves along with the shell 102,slides over the pin's 212 shaft, and engages with a detent ridge 215 ofthe pin 212. At this point the pin 212 is retained to the shell 102. Aslot 231 in the shell 102 allows connecting an anchoring link (hereafter sometimes referred to as the anchoring link) such as a strap orother devices to facilitate pulling the shell 102 to the extendedposition. In FIG. 2d the shell 102 is moved down, carrying along the pin212 which pierces the pierceable region of the pressurized cartridge211, thereby pressurizing the pressure chamber 104. The pressurizedcanister 211 may contain carbon dioxide, nitrogen, argon, or othergasses or supercritical fluids. When the pressure in the pressurechamber 104 exceeds a first threshold value, the force it exerts on thepiston 112 overcomes the spring 113 force, moving the piston 112 towardthe proximal injection end 101. The needle assembly 140 moves with thepiston 121 until it is stopped by the needle housing 101 floor, at whichpoint the needle 141 is fully extend. With the needle assembly 140 nowstationary, the pressure in the pressure chamber 104 continues to movethe piston 121 down, resulting in a relative movement between the needleassembly 140 and the piston 121, causing the distal end of the needle141 to pierce the package assembly 130 and establish fluid communicationwith the beneficial agent. With the pressure chamber 104 stillpressurized, the beneficial agent is squeezed out of the package 130 andadministered via the needle 141 to a subject. In one arrangement theposition of the cam 221 relative to the compression panel 214, and theposition of the latch 222 relative to the detent ridge 215 are such,that a first move of the needle housing 112 changes the device 200 tothe mixing auto-injector 200 state, where the compartments of thepackage 130 are merged, and a subsequent second move moves the device200 to the third auto-injector state (here after sometimes referred toas the armed configuration). This arrangement is particularly beneficialwhere the beneficial agent is ready for injection only after a certaintime from mixing, such that the device can be kept at a safe, unarmedstate during mixing. FIG. 2e illustrates the auto-injector 200 in amanufacturing configuration. The needle housing 101 assembly is sterileand ready to fill at the filling site. Special access regions 233 in thepackage assembly 130 allows the filling machine to fill the package andsubsequently seal the channels 232 connecting the access regions 233 andthe compartments 134,135. When filling is completed the access regions233 may be removed and the shell 102 is installed on the needle housingassembly 250. An According to one aspect of the arrangement of FIG. 2a-d, the auto-injector 200 comprises: (a) an injector housing 102 having aninjection end 101, (b) an administration assembly 230, comprising thepiston assembly 120, the actuation assembly 210, and the needle housing112, disposed within the injector housing 102, the administrationassembly 230 having a delivery end 231 proximate to the injection end101 through which a beneficial agent housed within the administrationassembly 230 is capable of being expelled; when in the auto-injector 200state illustrated in FIGS. 2a-2b , the administration assembly 230 isrendered incapable of expelling the beneficial agent; and when in theauto-injector 200 state illustrated in FIG. 2c , the administrationassembly 230 is rendered capable of expelling the beneficial agent. Theadministration assembly 230 comprises a first compartment 134 forstoring at least a first constituent of the beneficial agent, and atleast a second compartment 135 for storing at least a second constituentof the beneficial agent separate from the first constituent; and whereinat the auto-injector state illustrated in FIG. 2c , the firstcompartment 134 and the at least second compartment 135 are merged.

FIG. 3a illustrates an auto-injector arrangement 330 and anauto-injector 300 in the first auto-injector state (hereafter can bereferred to as the pre-use configuration of an auto-injector 300)comprising an auto-injector housing comprising a shell 302. An actuatorin the form of a removable cap 311 is joined with the proximal end ofthe administration assembly 310, providing a sterile seal to the needlehousing 310. The cap 311 is joined to an anchoring link comprising astrap 312 that terminates with a buckle 313. The cap 311 comprisesdetent arms (not shown in FIG. 3a ), that reach into a gap between theouter diameter of the administration assembly 310 and the inner diameterof the shell 302, and fit in a circumferential recess on the outerdiameter of the administration assembly 310 (not shown in FIG. 3a ),such that when the strap 312 is pulled, as shown in FIG. 3b , it extendsthe administration assembly 310 away from the shell 302, thereby movingthe auto-injector 300 to a second auto-injector state (hereafter can bereferred to as the auto-injector 300 armed configuration). The detentteeth 314 can then be dislodged from the recess 315 in theadministration assembly 310, as shown in FIG. 3c , until the cap 311 iscompletely removed as shown in FIG. 3d . FIG. 3d illustrate the devicewhen it's ready for activation by depressing the administration assembly310 against a subject. In one arrangement, the auto-injector 300comprises at least two beneficial agent constituents, housed in theauto-injector body 302, that need to be mixed prior to injection, and amixing action is initiated when the cap 311 is moved to the mixingauto-injector arrangement state shown in FIG. 3b , and subsequently thedevice is armed upon a second move when the cap 311 is removed as shownin FIG. 3c . The buckle 313 can be attached to any anchoring bodyincluding the auto-injector's carrying receptacle (not shown), or in itsvicinity such as a garment of the user.

According to one aspect of the arrangement of FIGS. 3a to 3d , theauto-injector 330 arrangement, comprises: (a) an auto-injector 300comprising an injector body 302 housing a beneficial agent; and (b) anactuator 311 moveably connected to the auto-injector 300, the actuatorcomprising an anchoring link 320 adapted to be connected to an anchoringbody, wherein: when in a first auto-injector arrangement 330 state, theauto-injector 300 is rendered incapable of expelling the beneficialagent; and when in a second auto-injector arrangement 330 state,corresponding to the auto-injector 300 having being moved relative tothe anchoring body from the first auto-injector arrangement 330 state,the auto-injector 300 is rendered capable of expelling the beneficialagent. Moving the actuator from the first auto-injector arrangement 300state, illustrated in FIG. 3a , to the second auto-injector arrangement300 state, illustrated in FIG. 3b , comprises moving the actuator 311relative to the injector housing 302. In one arrangement, the sequencesteps illustrated in FIGS. 3b to 3d are combined, such that in thesecond auto-injector arrangement 300 state the actuator 311 is separatedfrom the auto-injector 300. In one arrangement the anchoring link 320comprises at least one of a strap, a clip, a chain, a cable, a lanyard,a hook or a combination thereof. In one arrangement, the actuator 311comprises a cap. In one arrangement, at the first auto-injectorarrangement 300 state, illustrated in FIG. 3a , the cap isolates atleast a portion of the auto-injector 300 from the surroundingenvironment. In one arrangement the anchoring body comprises anauto-injector receptacle inside of which, in the first auto-injectorarrangement state, at least a portion of the auto-injector isaccommodated, and wherein the receptacle comprises at least one of anenclosure, a package, a bag, a pouch, a pocket, a belt, a container, aholster, a cradle, a kit, a garment, or any combination thereof. Therelative movement of the actuator 311 relative to the anchoring body, tomove the auto-injector arrangement from 300 from the first auto-injectorarrangement state to the second auto-injector arrangement state,comprises linear motion. In one arrangement the injector body 302comprises a first compartment for storing at least a first constituentof the beneficial agent, and at least a second compartment for storingat least a second constituent of the beneficial agent separate from thefirst constituent; and when in a mixing auto-injector arrangement state,corresponding to the auto-injector 300 having been moved relative to theanchoring body from the first auto-injector arrangement 330 state, thefirst compartment and the at least second compartment are merged and theauto-injector 300 is rendered incapable of expelling beneficial agent.In one arrangement transitioning the auto-injector arrangement 330 fromthe first auto-injector arrangement 330 state to the mixingauto-injector arrangement 330 state comprises a first movement of theauto-injector 300 relative to the anchoring body and transitioning theauto-injector arrangement 330 from the mixing auto-injector arrangement330 state to the second auto-injector arrangement 330 state comprises asecond movement of the auto-injector 300 relative to the anchoring body.In one arrangement the mixing auto-injector arrangement 300 state andthe second auto-injector arrangement state 330 are the same. In onearrangement the actuator 311 is separated from the auto-injector 300 inthe second auto-injector arrangement 330 state. In one arrangement theauto-injector 300 is removed from the receptacle in the secondauto-injector arrangement 330 state. In one arrangement theauto-injector further comprises a compressed gas source that when openedprovides gas pressure within the injector body 302 to expel thebeneficial agent, and wherein the compressed gas source is incapable ofopening in the first auto-injector arrangement 330 state, and thecompressed gas source is capable of being opened in the secondauto-injector arrangement 330 state. According to one aspect of theauto-injector arrangement 330, the injector body 302 comprises anactivation member 317, extending therefrom, which is the delivery end ofthe administration assembly 310, that when moved toward the injectorbody 302, activates the auto-injector 300 to expel the beneficial agent,and wherein the actuator 311 impedes the activation member 317 frommoving toward the injector body 302 in the first auto-injectorarrangement 330 state, illustrated in FIG. 3a . The activation member317 comprises a delivery end 318 from where the beneficial agent isexpelled.

According to one aspect of the auto-injector arrangement 330, theauto-injector 300, comprises: (a) an injector housing 302 having aninjection end 301; (b) an administration assembly 310 disposed withinthe injector housing 302, the administration assembly 310 having adelivery end 318 proximate to the injection end 301 through which abeneficial agent housed within the administration assembly 310 iscapable of being expelled; and (c) an actuator 311 moveably connected tothe administration assembly 310, wherein: when in a first auto-injector300 state, illustrated in FIG. 3a the actuator 311 is coupled to theadministration assembly 310 such that the delivery end 318 is renderedincapable of being applied to a subject and the administration assembly310 is rendered incapable of expelling the beneficial agent; and when ina second auto-injector 300 state, illustrated in FIG. 3b , correspondingto the actuator 311 having been manipulated from the first auto-injector300 state, the administration assembly 310 is rendered capable ofexpelling the beneficial agent, the auto-injector 300 thereafter movableinto a third auto-injector 300 state, illustrated in FIG. 3d , in whichthe actuator 311 is separated from the auto-injector. Manipulating theactuator 311 from the first auto-injector 300 state to the secondauto-injector 300 state comprises moving the actuator relative to theinjector housing 302. The actuator 311 is moveably connected to thedelivery end 318 of the administration assembly 311, but it would beobvious to one skilled in the art that the actuator 311 can be connectedto the administration assembly in other locations, such as the oppositeend of the injection end 301. In one arrangement the administrationassembly 310 comprises a first compartment for storing at least a firstconstituent of the beneficial agent, and at least a second compartmentfor storing at least a second constituent of the beneficial agentseparate from the first constituent; wherein at the second auto-injectorstate, the first compartment and the at least second compartment aremerged.

FIGS. 4a and 4b illustrate the auto-injector 300 nested in a carryingreceptacle in a form of a cradle or holster 411. The cradle comprises aprotective cover 412 and it can be strapped down to a person's arm,belt, leg, or a package, bag etc. The cradle 411 is configures such thatthe auto-injector 300 can be single handedly removed from the cradle411. The auto-injector may be removed by holding the shell (alsoreferred to as the auto-injector housing) 302 in substantially the samehand grasp that the auto-injector 300 should be held for activation,hence the auto-injector 300 can be removed from the carrying receptacle311, pulled off from the strap 312 for arming, and be depressed onto theinjection site in a single action, single handedly, at a substantiallysimilar hand grasp of the shell 302.

According to one aspect of the auto-injector arrangement 400, theauto-injector arrangement 400, comprises: (a) an auto-injector 300comprising an injector body 302 housing a beneficial agent; and (b) anactuator 311 moveably connected to the auto-injector 300, the actuator311 comprising an anchoring link 320 connected to an anchoring body 410comprising a holster 411; wherein: when in a first auto-injectorarrangement 400 state, illustrated in FIGS. 4a and 4b , theauto-injector is rendered incapable of expelling the beneficial agent;and when in a second auto-injector arrangement 400 state, correspondingto the auto-injector 300 having being moved relative to the anchoringbody 410, as illustrated in FIG. 4c , from the first auto-injectorarrangement 400 state, the auto-injector 300 is rendered capable ofexpelling the beneficial agent. Moving the actuator 311 from the firstauto-injector arrangement 400 state to the second auto-injectorarrangement 400 state comprises moving the actuator 311 relative to theinjector body 302. In one arrangement, in the second auto-injectorarrangement 400 state, the actuator 311 is separated from theauto-injector 300. In one arrangement the anchoring link 320 comprisesat least one of a strap, a clip, a chain, a cable, a lanyard, a hook ora combination thereof. The actuator 311 comprises a cap, and in onearrangement, at the first auto-injector arrangement 400 state, the capisolates at least a portion of the auto-injector 300 from thesurrounding environment. The anchoring body 410 comprises anauto-injector receptacle inside of which, in the first auto-injectorarrangement 400 state, at least a portion of the auto-injector 300 isaccommodated. In some arrangements the receptacle comprises at least oneof an enclosure, a package, a bag, a pouch, a pocket, a belt, acontainer, a holster, a cradle, a kit, a garment, or any combinationthereof. The relative movement of the auto-injector 300 relative to theanchoring body 410, from the first auto-injector arrangement 400 stateto the second auto-injector arrangement 400 state, comprises linearmotion. In one arrangement the injector body 302 comprises a firstcompartment for storing at least a first constituent of the beneficialagent, and at least a second compartment for storing at least a secondconstituent of the beneficial agent separate from the first constituent;and when in a mixing auto-injector arrangement 400 state, correspondingto the auto-injector 300 having been moved relative to the anchoringbody 410 from the first auto-injector arrangement 400 state, the firstcompartment and the at least second compartment are merged and theauto-injector 300 is rendered incapable of expelling beneficial agent.In one arrangement transitioning the auto-injector arrangement 400 fromthe first auto-injector arrangement 400 state to the mixingauto-injector arrangement 400 state comprises a first movement of theauto-injector 300 relative to the anchoring body 410, and transitioningthe auto-injector arrangement from the mixing auto-injector arrangement400 state to the second auto-injector arrangement 400 state comprises asecond movement of the auto-injector 300 relative to the anchoring body410. In one arrangement the mixing auto-injector arrangement 400 stateand the second auto-injector arrangement 400 state are the same. In onearrangement the actuator 311 is separated from the auto-injector 300 inthe second auto-injector arrangement 400 state. In one arrangement theauto-injector 300 is separated from the receptacle 400 in the secondauto-injector arrangement 400 state. In one arrangement theauto-injector 300 further comprises a compressed gas source that whenopened provides gas pressure within the injector body 302 to expel thebeneficial agent, and wherein the compressed gas source is incapable ofopening in the first auto-injector arrangement 400 state, and thecompressed gas source is capable of being opened in the secondauto-injector arrangement 400 state. In one arrangement the injectorbody 302 further comprises an activation member extending there fromthat, when moved toward the injector body 302, activates theauto-injector to expel the beneficial agent, and wherein the actuator311 impedes the activation member from moving toward the injector body302 in the first auto-injector arrangement 400 state. In one arrangementthe activation member comprises an injection end from where thebeneficial agent is expelled.

According to one aspect of the auto-injector arrangement 400, theauto-injector 300 comprises: (a) an injector housing 302 having aninjection end 301; (b) an administration assembly disposed within theinjector housing, the administration assembly having a delivery endproximate to the injection end through which a beneficial agent housedwithin the administration assembly is capable of being expelled; and (c)an actuator 311 moveably connected to the administration assembly,wherein: when in a first auto-injector 300 state, the actuator 311 iscoupled to the administration assembly 310 such that the delivery end isrendered incapable of being applied to a subject and the administrationassembly is rendered incapable of expelling the beneficial agent; andwhen in a second auto-injector 300 state, corresponding to the actuator311 having been manipulated from the first auto-injector 300 state, theadministration assembly is rendered capable of expelling the beneficialagent, the auto-injector 300 thereafter movable into a thirdauto-injector 300 state in which the actuator 311 is separated from theauto-injector. Manipulating the actuator 311 from the firstauto-injector 300 state to the second auto-injector 300 state comprisesmoving the actuator 311 relative to the injector housing. The actuator311 is moveably connected to the delivery end of the administrationassembly. In one arrangement the administration assembly comprises afirst compartment for storing at least a first constituent of thebeneficial agent, and at least a second compartment for storing at leasta second constituent of the beneficial agent separate from the firstconstituent; and wherein at the second auto-injector 300 state, thefirst compartment and the at least second compartment are merged.

FIGS. 5a and 5b illustrate another arrangement of an auto-injector 500where the piston 513 accommodates a first beneficial agent packageassembly 130 a, confronting a first needle 141 a, and a secondbeneficial agent package assembly 130 b confronting a second needle 141b. Each beneficial agent package assembly and needle assembly set isoperable in the same manner as the auto-injector arrangements 100, 200,300 described in earlier Figures, such that two injections can be givensimultaneously from the auto-injector 500 without changing the operationmode or the product 500 complexity. FIG. 5a illustrates theauto-injector 500 in an armed configuration and FIG. 5b illustrates theauto injector 500 when it is activated. In one arrangement at least oneof beneficial agent package assemblies 130 a and 130 b comprises morethan one compartment that are merge at or prior to the arming step.

According to one aspect of FIGS. 5a-5b , the auto-injector 500 isadapted for delivering to a patient at least a first beneficial agentand a second beneficial agent, comprising: (a) an auto-injector body 511comprising an injection end 512, (b) a piston 513 disposed in theauto-injector body 511 to form a pressure chamber 514, the piston 513 ismoveable from a pre-use position to a deployed position (c) a firstbeneficial agent communicable with a first administration device 141 ais connected to the piston 153, (d) a second beneficial agentcommunicable with a second administration device 141 b is connected tothe piston 153, wherein when pressure is applied in the pressure chamber514 the piston 513 moves to deploy the first and second administrationdevices 141 a and 141 b through the injection end 512, and the first andsecond beneficial agents are administered through their respectiveadministration devices.

FIGS. 6a-6c illustrate another arrangement of the auto-injector 600,activatable to administer a beneficial agent to a subject. FIG. 6aillustrates the auto-injector 600 at a first auto-injector state (hereafter sometimes referred to as the pre-use configuration). Anadministration assembly 620 (also referred to as the carriage assembly)comprises the package assembly 630, piston 621, and a needle assembly640. The package assembly 630 comprises a collapsible tube. The piston621 comprises a piston core component 626 and a piston skirt component627, that are latched together via a lateral ridge and groove joint.This joint is substantially fluid tight seal but for a bleedingpassageway 628 formed there between to deplete the pressure from thepressure chamber 605 after the device 600 has been activated. Thebleeding passageway 628 is formed as a torturous path (such as alabyrinth) that prevents bacteria and contamination from reaching intosterile needle chamber 604 before use. The spring 613 biases the pistoncore 626 toward the pressure chamber 605. In another arrangement thebleeding passageway is configured such that it only opens when thepiston is moved, for example by providing an inward protrusion (such asa rib) that comes off the needle housing 601 wall and interrupts theseal of the piston skirt 627 against that wall, when the piston 621reaches that protrusion as it travels down. FIG. 1b illustrates thedevice 600 when activated where the cartridge 691 has been ruptured,and, after exceeding a first pressure threshold value, the pressure inthe pressure chamber 605 has driven down the piston assembly 621 towardthe proximal end of the device 600. The pressured gas in the pressurechamber 605 is depleting through the bleeding passageway 628. The baseof the piston skirt 627 is latched with a detent ridge 619 inwardlyfacing from the needle housing 601 wall. FIG. 6c illustrates theauto-injector 600 after the pressure in the pressure chamber has droppedto below a second threshold value where the spring 613 was able torelease the piston core 626 from the piston skirt 627, and retract thepiston core 626 back toward the pressure chamber 605, carrying along theadministration assembly 620 (except for the skirt 627). The piston skirt627 remains latched at the bottom position. By separating the pistoncore 626 from the skirt 627 the pressure in the pressure chamber 605 isinstantly vented through opening 618 in the needle housing 601, allowingabrupt retraction of the administration assembly 620. The opening 618allows inspection that the auto-injector 600 has been operated byviewing the piston skirt 627 through this opening 618.

FIG. 7 illustrates an auto-injector 70 for delivering a first beneficialagent to a subject, comprising an auto-injector body having an elongatedshape, comprising an injection end 73 and a distal end 71 opposite tothe injection end 71. The distal end has a tactilely distinguishabletriangular shape. The auto-injector 70 may be intended to be stored, orcarried adjacent to at least a second auto-injector and the distal end71 shape allows for the user to tactilely distinguish the auto-injector70 from the at least a second auto-injector, for delivering a secondbeneficial agent, with a different distal end shape. The auto-injector70 further comprises graphics 72 of triangular shape which allow avisual recognition of the auto-injector that corresponds to the tactilerecognition of the auto-injector 70. The end piece 71 may also bedistinguished from other auto-injectors by the color of the distal end71. The auto-injector 70. In one arrangement the injection end 73comprises a tactilely, graphical or color features that allowsdistinguishing the auto-injector 70 from other auto-injectors. In oneembodiment at least one of the distinguishing features of the injectionend correlate to a distinguishing feature of the distal end. In onearrangement the injection 73 comprises a cap that bares thedistinguishing feature. The distal end 71 may be a cap mounted over theauto-injector 70 body.

FIGS. 8, 9, and 10 illustrates auto-injectors with distal ends ofdifferent shapes. FIG. 7 illustrates an auto-injector 70 comprising anornamental end piece 71 comprising a triangular shape. The end piece 71further comprises printed, stacked-on, or embossed triangular graphics72 that resemble the triangular shape of the end piece 72. Resembling.FIG. 8 illustrates an auto-injector 80 comprising an ornamental endpiece 81 comprising a pointed shape. FIG. 9 illustrates an auto-injector90 comprising an ornamental end piece 91 comprising a rounded shape. Thedistal end of FIG. 9 comprises graphic 92 of a circular shape thatcorrelates to the spherical shape of the distal end 91. FIG. 10illustrates an auto-injector 1000 comprising an ornamental end piece1001 comprising a flat screwdriver head shape. It would be obvious toone skilled in the art that corresponding ornamental shapes and graphicscan be applied to the opposite ends 73, 83, 93, and 1003 ofauto-injectors 70, 80, 90, and 1000 respectively. According to oneaspect of the auto-injectors 70,80,90, and 1000, a first auto-injectorfor delivering at least a first beneficial agent intended to be carriedor stored adjacent to at least a second auto-injector for delivering atleast a second beneficial agent, comprising a generally elongated bodycomprising an injection end 73, 83, 93, and 1003, and a distal end 71,81, 91, and 1001 opposite to the injection end, where at least one ofsaid ends comprises a tactile distinguishable shape from the at leastone end of the second auto-injector. According to another aspect ofFIGS. 7,8,9, and 10, a set of at least a first and a secondauto-injectors, each comprising a generally elongated body comprising aninjection end 73, 83, 93, and 1003, and a distal end 71, 81, 91, and1001 opposite to the injection end, at least one of said ends comprisesa shape, where said shape of the first auto-injector is tactilelydistinguishable from the shape of the at least second auto-injector. Theend of the first auto-injector can be distinguished from the at leastsecond auto-injector by at least one of a color, color pattern, andgraphics. In one arrangement the auto-injector at least one of theinjection end and the distal end comprises a cap and the shape is in thecap. The ornamental shapes can be at least one of a dome, a circle, atriangle, a square, a flat screwdriver head, a Philips screwdriver head,a star, a chess rook, a cone, or a combination or a blend of theformers. The shape and the graphics substantially represent the sameshape. In some arrangements the ornamental shape comprises at least oneof an indentations, a neck, a recess, through hole, or a blend or acombination of the formers. In some arrangements the shape comprises atleast one of indentations, recesses, grooves, notches, or a combinationor blend of the formers, arranged in a circumferential, longitudinal, orradial pattern, or a combination or a blend of the above.

FIG. 11a to FIG. 11f illustrate an auto-injector arrangement 1110activatable to deliver a beneficial agent to a subject by an operator,comprising an auto-injector 1115 comprising an auto-injector body 1111(hereafter can be referred to as auto-injector housing 1111) comprisingan injection end 1114, and an anchoring body comprising a receptacle1112, in a form of a holster, for accommodating therein at least aportion of the auto-injector body 1111 before use. The receptacle 1112can be mounted or otherwise joined to a belt, a garment, a gear, a bag,a package. FIGS. 11a and 11b illustrate the auto-injector arrangement1110 at a first configuration wherein the auto-injector body 1111 seatsclose to the holster 1112 and, when worn on a belt or other garment orgear, it is substantially protected from accidental impact orinterference. FIGS. 11c and 11d illustrate the auto-injector arrangement1110 at a second configuration where the auto-injector body 1111 istilted away from the holster 1112 to allow accessing the auto-injectorbody 1111 by the operator allowing accessibility for a firm hand grip.The arrangement is such that the auto-injector body 1111 is manipulablerelative to the receptacle 1112 from a first configuration, shown inFIGS. 11a and 11b , where the auto-injector body 1111 is substantiallyprotected from physical interferences (such as accidental andunintentional manipulation), to a second position where theauto-injector body 1111 is partially removed, and substantially extendedfrom the receptacle 1112 to facilitate the operator hand grasp of theauto-injector body 1111. According to one aspect of the presentdisclosure, the auto-injector is single handedly operable from a pre-useconfiguration to activation avoiding hand repositioning, therebyreducing the risk of accidentally dropping the device or disorienting itfor activation. In the second configuration the device can beconfidently hand grasped in the position for activation. In onearrangement the auto-injector 1115 in manipulable from a firstauto-injector state (may be referred to as the pre-use configuration),where activation is disabled, to second auto-injector state (may also bereferred to as an armed configuration), where activation is enabled, bya relative movement between the auto-injector body 1111 and thereceptacle 1112. The arrangement is such that the second configurationfacilitates the operator manipulation of the device from the firstauto-injector state to the second auto-injector state. In onearrangement the first and second configuration the activation of thedevice 1110 is disabled. The anchoring body 1112 is not limited to aholster fashion and can be fitted for a particular application, carryingor storing consideration, and may be of different forms and fashionsincluding a package, a bag, a pouch, a pocket, a container, a cradle, aclosure, and a cap, or any combination of the above. In one embodimentthe movement of the auto-injector 1115 from the anchoring body 1112comprises axial movement. FIGS. 11a-f further illustrate an actuator1116 comprising an anchoring link 1113 communicating between theanchoring body 1112 and the auto-injector 1115, to facilitatemanipulation of the auto-injector 1115. The actuator 1116 is in a formof a cap that extends from the auto-injector body 1111, and covers theinjection end of the auto-injector. In FIGS. 11e and 11f the device 1111is armed by pulling the auto-injector 1115 away from the actuator 1116which remains connected to the anchoring body 1112 via anchoring link1113. The anchoring link 1113 form is not limited to that shown in thisfigure and can comprise at least a closure, a strap, a clip, a chain, acable, lanyard, or a combination of the formers. In one embodiment, atthe first configuration the auto-injector 1115 is in the firstauto-injector state and cannot be moved to the second auto-injectorstate (armed configuration) without first moving to the secondconfiguration.

According to one aspect of FIGS. 11a-f , the auto-injector arrangement1110 is activatable to deliver a beneficial agent to a subject by anoperator. The auto-injector arrangement 1110 comprises: (a) anauto-injector 1115 comprising an auto-injector body 1111 comprising aninjection end 1114, and (b) an anchoring body 1112 comprising areceptacle for accommodating at least a portion of the auto-injectorbody therein before use, the arrangement is such that the auto-injector1115 is manipulable relative to the anchoring body 1112, from a firstposition where the auto-injector body is substantially protected fromphysical interferences (such as accidental and unintentionalmanipulation), and a second position where the auto-injector 1115 issubstantially extended from the anchoring body 1112 to facilitate theoperator hand grasp of the auto-injector body 1111. The auto-injectorarrangement 1115 is further manipulable from a first auto-injector 1115state (pre-use configuration), where activation is disabled, to a secondauto-injector 1115 state (an armed configuration), where activation isenabled, and where the arrangement is such that the second configurationfacilitates the operator manipulation of the auto-injector 1115 from thefirst auto-injector state to the second auto-injector state. In onearrangement at the first and the second configurations, theauto-injector 1115 activation is disabled. In one arrangement theauto-injector 1115 is moved from the first auto-injector state (thepre-use configuration) to the second auto-injector state (armedconfiguration) when it is separated from the anchoring body 1112.

According to one aspect of FIGS. 11e and 11f , the auto-injectorarrangement 1110, comprises: (a) an auto-injector 1115 comprising aninjector body 1111 housing a beneficial agent; and (b) an actuator 1116moveably connected to the auto-injector 1115, the actuator comprising ananchoring link 1113 adapted to be connected to an anchoring body 1112,wherein: when in a first auto-injector arrangement 1110 state, theauto-injector 1115 is rendered incapable of expelling the beneficialagent; and when in a second auto-injector arrangement 1110 state,corresponding to the auto-injector 1115 having being moved relative tothe anchoring body 1112 from the first auto-injector arrangement 1110state, the auto-injector 1115 is rendered capable of expelling thebeneficial agent. Moving the auto-injector 1115 from the firstauto-injector arrangement state 1110 to the second auto-injectorarrangement 1110 state further comprises moving the actuator 1116relative to the injector housing 1112. In one arrangement, in the secondauto-injector arrangement 1110 state the actuator 1116 is separated fromthe auto-injector 1115. In one arrangement the anchoring link 1113comprises at least one of a strap, a clip, a chain, a cable, a lanyard,a hook or a combination thereof. The actuator 1113 comprises a cap, andin one arrangement, at the first auto-injector arrangement 1110 state,the cap 1113 isolates at least a portion of the auto-injector 1115 fromthe surrounding environment. The anchoring body 112 comprises anauto-injector receptacle in a form of a holster, inside of which, in thefirst auto-injector arrangement 1110 state, at least a portion of theauto-injector 1115 is accommodated. In some arrangement the receptacle1112 comprises at least one of an enclosure, a package, a bag, a pouch,a pocket, a belt, a container, a holster, a cradle, a kit, a garment, orany combination thereof. In one arrangement the injector body 1111comprises a first compartment for storing at least a first constituentof the beneficial agent, and at least a second compartment for storingat least a second constituent of the beneficial agent separate from thefirst constituent; and when in a mixing auto-injector arrangement state,corresponding to the auto-injector 1115 having been moved relative tothe anchoring body 1112 from the first auto-injector arrangement 1110state, the first compartment and the at least second compartment aremerged and the auto-injector 1115 is rendered incapable of expellingbeneficial agent. In one arrangement transitioning the auto-injectorarrangement 1110 from the first auto-injector arrangement state to themixing auto-injector arrangement state comprises a first movement of theauto-injector 1115 relative to the anchoring body 1112 and transitioningthe auto-injector arrangement 1110 from the mixing auto-injectorarrangement to the second auto-injector arrangement state comprises asecond movement of the auto-injector 1115 relative to the anchoring body1112. In one arrangement the mixing auto-injector arrangement 1110 stateand the second auto-injector arrangement 1110 state are the same. In onearrangement the actuator 1116 is separated from the auto-injector 1115in the second auto-injector arrangement 1110 state. In one arrangementthe auto-injector 1115 is removed from the receptacle in the secondauto-injector arrangement 1110 state. In one arrangement theauto-injector 1115 further comprises a compressed gas source that whenopened provides gas pressure within the injector body 1111 to expel thebeneficial agent, and wherein the compressed gas source is incapable ofopening in the first auto-injector arrangement 1110 state, and thecompressed gas source is capable of being opened in the secondauto-injector arrangement 1110 state. The injector body 1111 comprisesan activation member 1117 extending therefrom that, when moved towardthe injector body 1111, activates the auto-injector 1115 to expel thebeneficial agent, and wherein the actuator 1116 impedes the activationmember 1117 from moving toward the injector body 1111 in the firstauto-injector arrangement 1110 state. The activation member comprises aninjection end 1119 from where the beneficial agent is expelled.

According to one aspect of the auto-injector arrangement 1110, theauto-injector 1115, comprises: (a) an injector housing 1111 having aninjection end 1114; (b) an administration assembly 1121 disposed withinthe injector housing, the administration assembly 1121 having a deliveryend 1119 proximate to the injection end 1114 through which a beneficialagent housed within the administration assembly 1121 is capable of beingexpelled; and (c) an actuator 1116 moveably connected to theadministration assembly 1121, wherein: when in a first auto-injector1115 state, the actuator 1116 is coupled to the administration assembly1121 1121 such that the delivery end 1119 is rendered incapable of beingapplied to a subject and the administration assembly 1121 is renderedincapable of expelling the beneficial agent; and when in a secondauto-injector 1115 state, corresponding to the actuator 1116 having beenmanipulated from the first auto-injector 1115 state, the administrationassembly 1121 is rendered capable of expelling the beneficial agent, theauto-injector 1115 thereafter movable into a third auto-injector 1115state in which the actuator 1116 is separated from the auto-injection1115. Manipulating the actuator 1116 from the first auto-injector 1115state to the second auto-injector 1115 state comprises moving theactuator 1116 relative to the injector housing. In one arrangement theadministration assembly 1121 comprises a first compartment for storingat least a first constituent of the beneficial agent, and at least asecond compartment for storing at least a second constituent of thebeneficial agent separate from the first constituent; and wherein at thesecond auto-injector 1115 state, the first compartment and the at leastsecond compartment are merged.

FIGS. 12a and 12b illustrate an auto-injector arrangement 1220activatable to administer a beneficial agent to a subject comprising anauto-injector 1210 comprising: (a) an auto-injector body 1221,comprising an injection end 1226, and (b) an actuator 1222, wherein, atthe first auto-injector state (peruse configuration) shown in FIG. 12a ,is mounted on the injection end 1226. The auto-injector arrangement 1220is moveable from a first auto injector state (pre-use configuration)where activation is disabled, to a second auto-injector state (an armedconfiguration) where activation is enabled. The auto-injector body 1221comprises helical ramps 1225, and the actuator 1222 comprises reciprocalhelical ramps 1223 such that at the first auto-injector 1210 state, whenthe cap is rotated counter clock wise the auto-injector 1210 is movedfrom the first auto-injector 1210 state to the second auto-injector 1210state, thereafter the auto-injector 1210 is separated from the actuator1222 as shown in FIG. 12b . The actuator 1222 can be joined to ananchoring body for instance by threading a strap, or a band (i.e.anchoring link) in through hole 1229 such that rotating theauto-injector 1210 relative to the anchoring body will move theauto-injector 1210 from the first auto-injector state to the secondauto-injector state. The anchoring body may be a garment, a package, abag a pouch, a kit, a container, an enclosure, a combination thereof, orother objects that the auto-injector may need to connect to. Accordingto one aspect of the auto-injector arrangement 1220, the auto-injector1210, comprises: (a) an injector housing 1221 having an injection end1211; (b) an administration assembly 1212 disposed within the injectorhousing 1221, the administration assembly 1212 having a delivery end1213 proximate to the injection end 1211 through which a beneficialagent housed within the administration assembly 1212 is capable of beingexpelled; and (c) an actuator 1222 moveably connected to theadministration assembly 1212, wherein: when in a first auto-injector1210 state, the actuator 1222 is coupled to the administration assembly1212 such that the delivery end 1119 is rendered incapable of beingapplied to a subject and the administration assembly 1212 is renderedincapable of expelling the beneficial agent; and when in a secondauto-injector 1210 state, corresponding to the actuator 1116 having beenmanipulated from the first auto-injector 1210 state, the administrationassembly 1212 is rendered capable of expelling the beneficial agent, theauto-injector 1210 thereafter movable into a third auto-injector 1210state in which the actuator 1222 is separated from the auto-injection1210. Manipulating the actuator 1222 from the first auto-injector 1210state to the second auto-injector 1210 state comprises moving theactuator 1222 relative to the injector housing 1221. In one arrangementthe administration assembly 1212 comprises a first compartment forstoring at least a first constituent of the beneficial agent, and atleast a second compartment for storing at least a second constituent ofthe beneficial agent separate from the first constituent; and wherein atthe second auto-injector 1210 state, the first compartment and the atleast second compartment are merged.

FIGS. 13a to 13n illustrate an auto-injector 1300 of the presentdisclosure in several operation sequence configurations. Theauto-injector 1300 is activatable to administer a beneficial agent to asubject. The auto-injector 1310, comprises: (a) an injector housing 1301(also referred to as auto-injector body 1301) having an injection end1307; (b) an administration assembly 1310 disposed within the injectorhousing 1301, the administration assembly 1310 having a delivery end1316 proximate to the injection end 1307 through which a beneficialagent housed within the administration assembly 1310 is capable of beingexpelled; and (c) an actuator 1302 (also referred to as cap 1302 orsterile cap 1302) moveably connected to the administration assembly1310, wherein: when in a first auto-injector 1300 state, the actuator1302 is coupled to the administration assembly 1310 such that thedelivery end 1316 is rendered incapable of being applied to a subjectand the administration assembly 1310 is rendered incapable of expellingthe beneficial agent; and when in a second auto-injector 1300 state,corresponding to the actuator 1302 having been manipulated from thefirst auto-injector 1300 state, the administration assembly 1310 isrendered capable of expelling the beneficial agent, the auto-injector1300 thereafter movable into a third auto-injector 1300 state in whichthe actuator 1302 is separated from the auto-injection 1300.Manipulating the actuator 1302 from the first auto-injector 1300 stateto the second auto-injector 1300 state comprises moving the actuator1302 relative to the injector housing 1301. In one arrangement theadministration assembly 1310 comprises a first compartment for storingat least a first constituent of the beneficial agent, and at least asecond compartment for storing at least a second constituent of thebeneficial agent separate from the first constituent; and wherein at thesecond auto-injector 1300 state, the first compartment and the at leastsecond compartment are merged.

FIGS. 13a and 13b illustrate longitudinal cross-sections of theauto-injector 1300 in a first auto-injector state (also referred to asthe pre-use configuration). The auto-injector 1300 comprises an injectorhousing 1301 (also referred to as the auto-injector housing 1301 or theauto-injector body 1301) comprising an injection end 1307, asepticallyprotected by a sterile cap 1302, and an ornamental end piece 1303 joinedto the distal end 1304 opposite to the injection end 1307. Anadministration assembly 1310 is axially moveable in the auto-injectorbody 1301 between a pre-use position, an armed position, and anactivated position, corresponding to the first auto-injector state, thesecond auto-injector state, and the third auto-injector staterespectively, as will be described hereunder. The administrationassembly 1310 comprises a carriage 1311, a piston assembly 1330, aneedle assembly 1360 and a beneficial agent package 1333. Theadministration assembly 1310 is air tight sealed against theauto-injector body via an O-ring seal 1313 and a wiper seal 1312. Thewiper seal provides for a lower friction force as the administrationassembly 1310 moves relative to the body 1301, and avoid sticking thatsometimes occur when an O-ring is compressed against a sealing surfacefor an elongated time. A piston assembly 1330 is moveably disposed inthe carriage 1311 and divides the internal volume of the auto-injectorbody 1310 into a pressure chamber 1305 and a sterile needle housing1306. The piston assembly 1330 comprises a piston core 1331 and a pistonwiper seal 1332 moveably joined in a fluid tight fashion. The pistonwiper seal 1332 is moveably sealed in a fluid tight fashion with theneedle housing walls 1306. A beneficial agent package 1333 in a form ofa tube is disposed in the pressure chamber 1305 and is joined to thedistal end of the piston core 1331, such that the spout of the tube isconfronting a membrane 1334. The beneficial agent package 1333 comprisesa compartment for storing at least one constituent of a beneficialagent, and a connector for joining the package 1333 to the piston core1331. In one arrangement the package 1333 comprises a membrane 1335 foraseptically sealing the beneficial agent. The piston core 1331 isaxially biased by a biasing mechanism 1350 comprising a spring 1351, toseat against stopper 1314—an inner circumferential ridge protruding fromthe carriage 1311. A needle assembly 1360 is disposed in the needlehousing 1306 and is moveably joined to the proximal end of the pistoncore 1331. The needle assembly 1360 comprises a hypodermic needle 1361,having a proximal hypodermic bevel tip 1363, and a distal sharp tip 1364configured to pierce into the beneficial agent package 1333; and aneedle hub 1362. The needle hub 1362 is moveably disposed in a bore inthe piston core 1331 in such a manner that substantial force is requiredto axially move the needle assembly 1360 relative to the piston core1331. The force required to move the needle assembly 1360 relative tothe piston core 1331 can be calibrated by several means includinginterference features, and friction. The proximal needle tip 1363 isreceived at the needle abutment 1315, confronting an opening in thedelivery end 1316 in the administration assembly 1310. At this pre-useconfiguration the needle is concealed in the auto-injector body and ismaintained sterile in the aseptically sealed needle housing 1306 by theaseptic cap 1302. The aseptic cap inner circumferential ridge 1308 sealsagainst the cap detent ridge 1317 of the carriage 1311. The edge of thecap 1302 is confined in the auto-injector body, preventing the capcircumferential ridge 1308 from expanding and dislodging from the capdetent ridge 1317 of the carriage 1311. A compressed gas source in aform of metal cartridge 1321 is supported at the distal end of theauto-injector body 1301 in the pressure chamber 1305, and comprises arupturable membrane, 1322 oriented toward the injection end 1307. Anarming mechanism 1370 is moveably joined at the distal end of thecarriage 1311. The arming mechanism 1370 comprises a piercing arm 1371and a piercing element 1372 biased by torsion spring 1373 from a pre-useposition, where the piercing element is not aligned with the cartridgemembrane 1322 (as is clearly illustrated in FIG. 13b and later in FIG.14a ), to the armed position, which is illustrated in subsequentFigures. The piercing arm protrusion 1374 leans against the cartridge1321 and prevent the piercing element 1371 from aligning with thecartridge membrane 1322. This arrangement of the arming mechanism isadvantageous for its inherent safety as the piercing element 1372 cannotpierce the cartridge 1321 regardless of the force applied to theauto-injector body. Actuator 1302 comprises a through pass 1318 forhooking the auto-injector body 1301 to an anchoring link such as alanyard, a chain, a ring, a strap or other form of attachments known inthe art. In one arrangement the actuator 1302 is configured to connectto a receptacle wherein at least a portion of the auto-injector body1301 is accommodated for storage or carrying. Forms of receptacles forauto-injector 1300 can be, but not limited to, a holster, a bracket, acradle, a closure, a package, a bag, a pocket, a purse, a tube and acombination of the above.

In one arrangement the compressed gas source is at least partiallyexternal to the auto-injector body. In one such example the gas issupplied by a hose to the pressure chamber 1305. A valve, or apierceable membrane can be accommodated in the auto-injector body 1301to control the introduction of pressure to the pressure chamber 1305.

The carriage can be formed from an assembly of parts that are joined bythreads, screws, welding, gluing or other means known in the art such asin the arrangement illustrated in FIG. 14 c.

FIGS. 13c and 13d illustrate cross section views of the auto-injector1300 in the second auto-injector state (also referred to as the armedconfiguration). The administration assembly 1310 is axially movedrelative to the auto-injector body 1301 toward the injection end 1307,from its pre-use position to the armed position, at which point thepiercing arm protrusion 1374 (not shown) disengages from the side of thegas cartridge 1321, allowing the torsion spring 1373 to move thepiercing arm 1371 to the armed position where the piercing element 1372is in a confronting position with the cartridge membrane 1322. A similararrangement of the arming mechanism is illustrated in FIG. 15a and FIG.15b and can provide further clarity to the principle of operation ofthis arming mechanism. The cap 1302 edge is dislodged from behind theauto-injector body 1301 allowing it to radially expand and to be removedfrom the cap detent ridge 1317 of the carriage 1311. The administrationassembly 1310 can be manipulated from the pre-use position to the armedposition by pulling the cap 1302 away from the auto-injector body 1301.In some arrangements the cap 1302 is attached to an anchoring link or ananchoring body such that the movement from the pre-use configuration tothe armed configuration can be accomplished by merely grasping theauto-injector body in the palm and single-handedly moving it relative tothe anchoring link or the anchoring body.

FIGS. 13e and 13f illustrate cross section views of the auto-injector1300 in the third auto-injector state when the cap 1302 is removed andthe auto-injector 1300 is ready for injection. The use indicationwindows 1319 are exposed when the cap 1302 is removed. In somearrangements the cap 1302 is connected to an anchoring link or areceptacle and is removed by merely grasping the auto-injector body 1301in the palm and moving it relative to the anchoring link or thereceptacle. In one arrangement the auto-injector 1300 is moved from thefirst auto-injector state (pre-use configuration) illustrated in FIG.13a-b , to the third auto-injector state (armed configuration with thecap 1302 removed) as shown in FIG. 13e-f in a single continuous action.Accordingly, in an arrangement where the cap 302 is connected to ananchoring link or an anchoring body, the auto-injector 1300 is movedfrom the first auto-injector state to the third auto-injector statewhere it is ready for injection by separating it from the anchoring linkor the anchoring body, in a single hand operation, which is a uniquefeature of the present disclosure.

FIGS. 13g and 13h provide longitudinal cross-sections of theauto-injector 1300, showing a snapshot of the device as it is activatedto expel the beneficial agent. The administration assembly 1310 is movedrelative to the auto-injector body 1301 toward its distal end, causingthe piercing element to pierce through the cartridge membrane 1322,thereby opening the pressure source 1321, allowing the compressed gas tofill the pressure chamber 1305. Several type of gas can be loaded in thecartridge 1321 in a gaseous or two-phase form including nitrogen, argonand carbon-dioxide. The administration assembly 1310 can be moved fromthe armed position to the activated position by grasping theauto-injector body 1301 in the palm in substantially the same handgrasped used to move the auto injector 1300 from the first auto-injectorstate to the second and third auto-injector state, and pressing theinjection end 1307 against the subject's target injection site. In onearrangement the palm grasp of the auto-injector body 1301 for activatingthe auto-injector 1300 is substantially the same as the palm grasp usedto move the auto-injector body from the pre-use configuration to thearmed configuration, hence, combined with the arrangement described inthe discussion of FIGS. 13e-f , in this arrangement the auto-injector1300 can be operated from a pre-use configuration to an activation in asingle hand operation without changing the palm grasp, which is a uniquefeature of the present disclosure that simplify the device 1300operation and reduces the room for user errors.

FIGS. 13i and 13j provide longitudinal cross-sections of theauto-injector 1300, showing a snapshot of the device in the activationposition shortly after the cartridge 1321 is pierced and the pressurechamber 1305 is pressurized. When the pressure at the pressure chamber1305 surpasses a first threshold value, it exerts a force on the pistonassembly 1330 that overcomes the preloaded biasing spring 1351 force,causing the piston assembly 1330 to move, together with the package 1333and the needle assembly 1360, toward the injection end 1307, whileextending the needle 1361 through the opening in the delivery end 1316.The needle 1306 reaches its extended position when the needle hub 1362is stopped by the needle abutment 1315. The package 1333 is still not incommunication with the needle, preventing injection of the beneficialagent before the needle 1361 has reached its fully extended position. Asthe pressure in the pressure chamber 1305 continues to force the pistonassembly toward the injection end 1307, a relative movement between theneedle assembly 1360 and the piston assembly 1303 is initiated asillustrated in FIGS. 13k -l.

FIGS. 13k and 13l provide longitudinal cross-sections of theauto-injector 1300 during injection. The pressure in the pressurechamber 1305 continued to move the piston assembly 1330 toward theinjection end 1307. With the needle assembly 1360 now stationary, thepiston assembly 1330 moves relative to the needle assembly 1360 causingthe back end of the needle 1364 to pierce the piston core membrane 1334and the tube membrane 1335, and establish fluid communication betweenthe package 1333 and the needle 1361, allowing the beneficial agent tobe administered. The pressure in the pressure chamber 1305 compressesthe package 1333 to deliver the beneficial agent. As would be obvious tothose skilled in the art, several packages are practically applicablefor this auto-injector 1300 beside a tube, so long as they provide theadequate connection to the piston core 1331 and that their volume can bedepleted by applying pressure to at least one of their walls. Suchpackages include, but are not limited to, metal tubes, laminated tubes,plastic tubes, molded tubes, tubes made from extruded material, blowmolded packages, Blow-Fill-Seal packages, blister packages, pouch,sachet, bags, injection molded packages, and piston-barrel arrangements,and combination of the formers. In some arrangement of theauto-injector, one of the package membrane 1335 and piston core membrane1334 is eliminated. The purpose of these membranes 1335, 1334 is tomaintain the needle housing 1306 and the package 1333 asepticallysealed, however, as will be demonstrated in the description of FIG. 14,in certain manufacturing procedures of the auto-injector 1300 the pistoncore 1331 and the package 1333 are joined prior to filling of thebeneficial agent, and prior to sterilization of the needle housing 1306,thus one membrane can provide the aseptic seal of the needle housing1306 and the package 1333. In one arrangement the piercing element isother than the distal tip of the needle 1364. In one arrangement theneedle 1361 terminates in the needle hub 1362 and the piercing elementextends from the distal end of the needle hub 1362 either as a protrudedextension of the needle hub 1362 or a separate part that is joined tothe needle hub 1362 and extends from its distal end. When the pistonassembly 1330 reaches the final activation position, the piston wiper islocated under bleeding holes 1309 allowing the compressed gas to ventfrom the pressure chamber 1305. The pressure bleeding is used to controlthe dwelling time of the needle 1361 in the extended position, to allowenough time for the beneficial agent administration. This arrangement isparticularly beneficial as the pressure bleeding cannot occur until theneedle 1361 is fully extended, ensuring that: a) maximum pressure isavailable to force the needle insertion, and b) accurate timing of theneedle dwelling in the extended position. As more clearly noticed inFIGS. 13a-b , bleeding holes 1309 of several sizes are embedded in theneedle housing 1306 wall. These bleeding holes 1309 can be sealed,leaving the desired bleeding holes 1309 open, to achieve a desiredbleeding rate, i.e. a desired dwell time. Other controllable bleedingpassageway can be implemented to vent the pressure chamber including avalve, a labyrinth, etc. The bleeding holes 1309 are covered with afilter 1381 such as a Tyvek breathable laminate to prevent contaminationof the needle housing 1305 prior to use of the device 1300. Piston wiperseal 1332 is now showing in the use indication windows 1319, indicatingthat the needle 1361 is fully extended and that the beneficial agentadministration is taking place.

FIGS. 13m and 13n provide longitudinal cross-sections of theauto-injector 1300 after the needle 1361 has retracted. When thepressure in the pressure chamber drops under a second threshold pressurevalue, the spring 1351 moves the piston core 1331 away from theinjection end 1307, separating from the piston wiper seal 1332 which isretained in its activated position due to a combination of friction withthe needle housing 1306 wall and interference of the wiper seal lip 1383with inward protrusions 1382. As soon as the piston core starts its backtravel, the seal between the piston core 1331 and the piston wiper sealis breached, causing a sudden drop of pressure in the pressure chamber1305 to the surrounding pressure. With no pressure in the pressurechamber 1305 and no seal friction force to counter, the spring 1351force causes the piston core 1331, together with the needle assembly1360, to abruptly retract to the pre-use position. This is particularlyadvantageous as: a) slow needle retraction can cause discomfort to thesubject, and b) the abrupt needle retraction provides a tactileconfirmation to the user/operator that injection is completed, and c) itreduces the chance of needle 1361 exposure after the device 1300 hasbeen removed from the subject.

According to one aspect of the arrangement of FIGS. 13a to 13n , theauto-injector 1300 comprises an injector body 1301 housing a beneficialagent; and an actuator 1302 moveably connected to the auto-injector1300, the actuator 1302 is adapted to be connected to an anchoring linkwhich is adapted to be connected to an anchoring body, wherein: when ina first auto-injector 1300 state, corresponding to FIGS. 13a-b , theauto-injector is rendered incapable of expelling the beneficial agent;and when in a second auto-injector 1300 state, corresponding to FIGS.13c-d where the auto-injector 1300 having being moved relative to theanchoring body from the first auto-injector 1300 state, theauto-injector 1300 is rendered capable of expelling the beneficialagent. Moving the auto-injector 1300 from the first auto-injector stateto the second auto-injector state further comprises moving the actuator1302 relative to the injector housing 1301. In one arrangement, in thesecond auto-injector 1300 state the actuator 1302 is separated from theauto-injector 1301. In one arrangement the anchoring link comprises atleast one of a strap, a clip, a chain, a cable, a lanyard, a hook or acombination thereof. In one arrangement the injector body 1301 comprisesa first compartment for storing at least a first constituent of thebeneficial agent, and at least a second compartment for storing at leasta second constituent of the beneficial agent separate from the firstconstituent; and when in a mixing auto-injector state, corresponding tothe auto-injector having been moved relative to the anchoring body fromthe first auto-injector state, the first compartment and the at leastsecond compartment are merged and the auto-injector 1300 is renderedincapable of expelling beneficial agent. In one arrangementtransitioning the auto-injector 1300 from the first auto-injector stateto the mixing auto-injector state comprises a first movement of theauto-injector 1300 relative to the anchoring body and transitioning theauto-injector 1300 from the mixing auto-injector state to the secondauto-injector state comprises a second movement of the auto-injector1300 relative to the anchoring body. In one arrangement the mixingauto-injector state and the second auto-injector state are the same. Inone arrangement the actuator 1302 is separated from the auto-injector1300 in the second auto-injector state. In one arrangement theauto-injector 1300 is removed from the anchoring body in the secondauto-injector state. According to one aspect of the arrangement of FIGS.13a-13n , the delivery end 1316 of the administration assembly 1310 actsas an activation member extending from the auto-injector body 1301 and,when moved toward the injector body 1301, the activation memberactivates the auto-injector 1300 to expel the beneficial agent, andwherein the actuator 1302 impedes the activation member from movingtoward the injector body 1301 in the first auto-injector state.

According to one aspect of the arrangement of FIGS. 13a-13m , theauto-injector 1300 comprises: (a) an auto-injector body 1311 comprisingan injection end 1307, (b) a needle assembly 1360 moveable from apre-use position, where the needle assembly is concealed in theauto-injector body 1311, to a deployed position where the hypodermic tipof the needle 1361 extends from the auto-injector body 1307, (c) abiasing mechanism 1350 configured to bias the needle assembly 1360 tothe pre-use position, (d) a pressure chamber 1305 (also referred to aspressure capsule 1305), and (e) a pressure release valve that, whenopened, vents the pressure capsule; wherein when compressed gas pressurein the pressure chamber 1305 exceeds a first threshold pressure value,the needle assembly 1360 is moved to the deployed position, and when thepressure in the pressure chamber 1305 drops under a second thresholdpressure value, the pressure release valve opens. The auto-injector 1300further comprises a pressure bleeding passageway 1309 configured togradually deplete the pressure in the pressure chamber 1305. Thepressure release valve is configured to instantly deplete the pressurein the pressure chamber 1305. When the pressure release valve opens, atleast a portion of the needle assembly abruptly retracts toward theauto-injector body 1311. The needle assembly 1360 is joined to amoveable piston 1330 that manipulates the needle 1361 from the pre-useposition to the deployed position, and the pressure release valve isincorporated in the piston 1330. The biasing mechanism 1350 isconfigured to manipulate the release valve to open. The needle assembly1360 is incorporated in the pressure release valve. The piston assembly1330 comprises a first portion (i.e. piston core 1331) and a secondportion (i.e. piston seal 1332), and the needle assembly 1360 is joinedto the piston first portion 1331, and the biasing mechanism 1350 is aspring 1351 disposed between the injection end 1307 and the piston firstportion 1331, such that the biasing mechanism 1350 manipulates therelease valve to open by moving the piston first portion 1331 relativeto the piston second portion 1332. The piston first portion 1331retracts the needle 1361 toward the pre-use position when the pressurerelease valve is opened. The piston second portion 1332 provides avisual indication that the piston 1330 has moved to the deployedposition. The bleeding passageway controls the timing of the opening ofthe pressure release valve.

According to one aspect of the arrangement of FIGS. 13a-13m , theauto-injector 1300 comprises: (a) an auto-injector body 1311 comprisingan injection end 1307, (b) a compressed gas source 1321, (c) a needleassembly 1360, (d) a needle biasing mechanism 1350, (e) a calibratedpressure bleeding passageway 1309, and a pressure release valve; whereinthe pressure profile produced by the combination of the pressure source1321, the bleeding passageway 1309, and the release valve produces asequence of: (f) deploying the needle 1361 from a pre-use position whereit is substantially concealed in the auto-injector body 1311 to extendthrough the injection end 1307, (g) retain the needle 1361 in thedeployed position for a defined time to deliver an injection, and (h)retract the needle 1361 toward the pre-use position.

According to one aspect of the arrangement of FIGS. 13a-13m , theauto-injector 1300 comprises: (a) a body 1311 comprising an injectionend 1307, (b) a needle assembly 1360 moveable from a pre-use position toa deployed position, (c) an indicator 1332 moveable from a pre-useposition to a deployed position; wherein when the needle assembly 1360is moved from the pre-use position to the deployed position, theindicator 1332 is moved from the pre-use position to the deployedposition, and when the needle assembly 1360 is removed from the deployedposition the indicator 1332 remains in the deployed position. The needleassembly 1360 and the indicator 1332 are moved to the deployed positionby a piston 1330. The piston assembly 1330 comprises at least a firstportion 1331 and a second portion 1332, and the needle assembly 1360 isjoined to the piston first portion 1331, and the piston second portion1332 comprises the indicator. The auto-injector body 1311 comprises atleast one indication window 1319, and the indicator 1332 shows in theindication window when in the deployed position. At its deployedposition the indicator 1332 indicates that the needle 1361 has beendeployed. In one arrangement at its deployed position the indicator 1332indicates that the auto-injector 1300 has been used.

FIGS. 14a to 14f illustrate another arrangement of the auto-injector1400 device of the present disclosure. The functionality of thisarrangement is the same as that of the auto-injector 1300 illustrated inFIGS. 13a-n , but the construction of the administration assembly 1411,and the auto-injector body 1401 is configured to allow for a certainmanufacturing process that will be described here under. FIGS. 14a and14e illustrate a sterile assembly, comprising the needle housing 1421,the piston assembly 1430 to which the package 1433 is joined on itsdistal side, and the needle assembly 1460 is joined on its proximalside. The needle assembly 1460 is aseptically enclosed in the needlehousing 1421. The sterile assembly 1420 can be provided to thebeneficial agent filling site and filling equipment when it is presterilized and properly packaged to maintain sterility. The package 1433is open at its distal side 1433 to allow filling of the beneficialagent, which after the distal end of the package 1434 is sealed. Thisfilling step is preferably done in aseptic conditions, however once thepackage 1433 is sealed the sterile assembly 1420 can be moved out of thecontrolled filling environment as all the components that requiresterility (i.e. the needle 1461, the beneficial agent, and the surfacesof the device that are to be in contact with the subject), areaseptically sealed. FIGS. 14b and 14f illustrate another filling processapproach of the device 1400 where the package 1433 is filled prior to itbeing joined to the piston assembly 1430. The sterile assembly 1420 canbe supplied sterile to the filing site in proper packaging. The pistoncore membrane 1434 provides an aseptic seal to the needle 1461 in theneedle housing 1421 when the package 1433 is not joined to the sterileassembly 1420. FIG. 14c illustrate the pressure chamber assembly 1440,comprising the auto-injector body 1401, the distal portion of theadministration assembly 1412, and arming mechanism 1470. In somearrangements the pressure chamber assembly 1440 doesn't need to besterile, and can be joined with the already filled sterile assembly 1420after the last has been out of the controlled environment. FIG. 14dillustrates the assembled device 1400 where the pressure chamber 1440 isjoined with the sterile assembly 1420 by coupling the female thread atthe distal end of the needle housing 1421 with the male thread of thedistal portion of the administration assembly 1412 to form the completeadministration assembly 1411.

FIG. 15a and FIG. 15b illustrate an arming mechanism, similar to the oneillustrated in device 1300 of FIGS. 13a-n . A piercing arm 1571comprises a cartridge piercing element 1572, and is biased toward thecartridge 1521 by the torsion spring 1573. FIG. 15a illustrates anarming mechanism in a safe state corresponding to the firstauto-injector state (pre-use configuration) where protrusion 1574 leansagainst the cartridge 1521 side, preventing the piercing arm from movingtoward the cartridge 1521. FIG. 15b illustrates the arming mechanism inan armed state corresponding to the second and third auto-injectorstates (armed configuration) in which the administration assembly 1521has been axially moved relative to the cartridge 1521, such that theprotrusion 1574 no longer leans against the cartridge 1521, allowing thepiercing arm 1571 to move to the armed position where the cartridgepiercing element 1522 is confronting the pierceable membrane 1522 of thecartridge 1521. In a subsequent activation step the cartridge 1521 isaxially moved toward the piercing arm 1571 causing the piercing element1522 to penetrate the cartridge membrane 1522.

The foregoing Figures and arrangements are provided by way of exampleand are not intended to limit the generality of this disclosure.

I claim:
 1. An auto-injector arrangement, comprising: an auto-injectorcomprising an injector body housing a beneficial agent wherein theinjector body comprises an activation member extending therefrom that,when moved toward the injector body, activates the auto-injector toexpel the beneficial agent from an injector end, and wherein an actuatorimpedes the activation member from moving toward the injector body in afirst auto-injector arrangement state; and an administration assemblyhoused within the injector body and moveable relative to the injectorbody; and the actuator moveably connected to the administrationassembly, the actuator comprising an anchoring link adapted to beconnected to an anchoring body, wherein; when in the first auto-injectorarrangement state, the auto-injector is rendered incapable of expellingthe beneficial agent; when in a second auto-injector arrangement state,the auto-injector is rendered capable of expelling the beneficial agent;and when the actuator is moved relative to the injector body, theadministration assembly is extended away from the injector body and theauto injector moves from the first auto-injector arrangement state tothe second auto-injector arrangement state.
 2. The auto-injectorarrangement of claim 1 wherein at the second auto-injector arrangementstate the actuator is separated from the administration assembly.
 3. Theauto-injector arrangement of claim 1 wherein the anchoring linkcomprises at least one of a strap, a clip, a chain, a cable, a lanyard,a hook or a combination thereof.
 4. The auto-injector arrangement ofclaim 1 wherein the actuator comprises a cap.
 5. The auto-injectorarrangement of claim 4 wherein at the first auto-injector arrangementstate, the cap isolates at least a portion of the auto-injector from thesurrounding environment.
 6. The auto-injector arrangement of claim 1wherein the anchoring body comprises an auto injector receptacle insideof which, in the first auto-injector arrangement state, at least aportion of the auto-injector is accommodated, and wherein the receptaclecomprises at least one of an enclosure, a package, a bag, a pouch, apocket, a belt, a container, a holster, a cradle, a kit, a garment, orany combination thereof.
 7. The auto-injector arrangement of claim 6wherein the auto-injector is separated from the receptacle in the secondauto-injector arrangement state.
 8. The auto-injector arrangement ofclaim 1 wherein the relative movement comprises at least one ofrotation, linear motion, or a combination thereof.
 9. The auto-injectorarrangement of claim 1, wherein: the injector body comprises a firstcompartment for storing at least a first constituent of the beneficialagent, and at least a second compartment for storing at least a secondconstituent of the beneficial agent separate from the first constituent;and when in a mixing auto-injector arrangement state, corresponding tothe auto-injector having been moved relative to the anchoring body fromthe first auto-injector arrangement state, the first compartment and theat least second compartment are merged and the auto-injector is renderedincapable of expelling beneficial agent.
 10. The auto-injectorarrangement of claim 9 wherein transitioning the auto- injectorarrangement from the first auto-injector arrangement state to the mixingauto-injector arrangement state comprises a first movement of theauto-injector relative to the anchoring body and transitioning theauto-injector arrangement from the mixing auto-injector arrangement tothe second auto-injector arrangement state comprises a second movementof the auto-injector relative to the anchoring body.
 11. Theauto-injector arrangement of claim 9 wherein the mixing auto-injectorarrangement state and the second auto-injector arrangement state are thesame.
 12. The auto-injector arrangement of claim 1 wherein theauto-injector further comprises a compressed gas source that when openedprovides gas pressure within the injector body to expel the beneficialagent, and wherein the compressed gas source is incapable of opening inthe first auto-injector arrangement state, and the compressed gas sourceis capable of being opened in the second auto-injector arrangementstate.